Med Devices (Auckl). 2026 May 29;19:595863. doi: 10.2147/MDER.S595863. eCollection 2026.
ABSTRACT
PURPOSE: Uncontrolled bleeding remains a major surgical challenge, increasing morbidity, operative time, and costs, highlighting the need for effective adjunctive hemostats. Veriset is a synthetic, absorbable patch that promotes clotting and provides mechanical hemostasis. While early studies show efficacy, real-world evidence across diverse settings is needed. This post-market, multicenter study evaluated the safety and effectiveness of Veriset in various surgical procedures.
METHODS: This observational, single-arm, prospective study was nested within Medtronic’s product surveillance registry. Sites were selected for procedural diversity (cardiovascular, soft-tissue, solid-organ), high Veriset use, and clinical study experience. Patients treated with Veriset as part of usual care were followed for 30 days post-procedure to monitor adverse events (AEs). The primary safety and effectiveness endpoints were device-related AEs within 30 days and hemostasis within 5 minutes, respectively. Secondary outcomes included time to hemostasis, length of hospital stay, and bleeding-site severity. Results were summarized using descriptive statistics and exact (Clopper-Pearson) confidence intervals.
RESULTS: Veriset was used on-label in 100 patients in cardiovascular (56), soft-tissue (18), solid-organ (18), and other (8) procedures. Most were performed via open surgery (90.0%), with 34% involving anastomoses. Median blood loss was 600 mL (interquartile range 200-1500), with transfusions in 24 patients. Of the 120 bleeding sites treated, pre-Veriset methods included sutures (55.8%, 67/120) and pressure (29.2%, 35/120). Bleeding was mostly mild/moderate (82.5%, 99/120). Device-related AEs occurred in 1 patient, with no deaths. Hemostasis within 5 minutes was achieved at 91.7% (110/120) of sites and in 96.0% (96/100) of patients. Median time to hemostasis was 2.0 minutes; median hospital stay was 7 days.
CONCLUSION: This study provides real-world evidence that Veriset is safe and suggests that it may be an efficacious and rapid adjunct for surgical hemostasis, including in high-risk cardiovascular and solid-organ procedures, supporting and extending prior trial data for routine clinical use.
CLINICALTRIALSGOV IDENTIFIER: NCT01524276, Dec 24, 2025.
PMID:42239929 | PMC:PMC13228841 | DOI:10.2147/MDER.S595863
